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Feasibility study of an intervention to reduce sedentary behaviour in people after stroke

Feasibility study of an intervention to reduce sedentary behaviour in people after stroke, part of the research programme: Reducing sedentary bEhaviour After sTrokeE

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN12246326
Enrollment
90
Registered
2019-08-07
Start date
2019-07-19
Completion date
Unknown
Last updated
2022-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke Circulatory System

Interventions

Objectives of the study relate to: 1. Feasibility of delivering each component of the intervention: clarify methods of delivery
identify contextual influences on implementation
examine the fidelity of intervention delivery and identify local individual/organisational barriers and facilitators to intervention delivery. 2. Exploration of costs and core resource
outcome returns) 6. Convene a Seminar to determine whether intervention, implementation methods and outcome assessment need revision before the definitive trial. There

Sponsors

Bradford Teaching Hospitals NHS Foundation Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Stroke survivors aged 16 years or over at the time of stroke 2. Confirmed primary diagnosis of new stroke and are still in receipt of active rehabilitation in a participating stroke service (either in hospital, at home or at an outpatient clinic) 3. Able to stand independently or with the help of one person (defined as Functional Ambulatory Categories 3-6) 4. Have been/are being discharged home to live in the community (not a care home)

Exclusion criteria

Exclusion criteria: 1. In receipt of end of life care (documented in medical notes) 2. Discharged (or planned discharge) to an address outside the remit of the participating stroke service (including care home)

Design outcomes

Primary

MeasureTime frame
As this is a feasibility study in preparation for a planned definitive trial a range of potential outcome measures are being tested for appropriateness. We wish to capture the physical, psychological and behavioural factors which may be affected by reducing time spent sitting. In this feasibility study we seek to gain information on the optimum assessments to use. The assessments below will be used but not all will necessarily be administered with all participants.

Secondary

MeasureTime frame
Potential outcome measures to be used in the definitive trial: 1. Patient-centred outcomes assessed by the WHODAS 2.0 2. Warwick-Edinburgh Mental Well-being Scale (positive mental wellbeing) 3. PHQ-9 (for depressive symptoms) 4. EQ-5D-5L, (plus any alternative candidate measure that may better capture relevant data, if one is identified) to assess health related quality of life and enable calculation of quality adjusted life years (QALYs) for the economic evaluation 5. Fatigue Assessment Scale 6. Time spent in sedentary behavior, assessed by use of the activPAL activity monitor, which will include: Sitting time (total); Sitting time accumulated in bouts >30 minutes; proportion of the day sedentary; Standing time; Stepping time; number of sit-to stand transitions; as measured by activity monitor 7. Sedentary Behaviour Questionnaire – Measure of Older Adults' Sedentary Time (MOST) and a sedentary behaviour Visual Analogue Scale 8. Nottingham Extended Activities of Daily Living (NEADL), this may be used in place of the WHODAS 2.0 9. Patients will also be asked to answer questions on whether they have fallen and whether or not this led to injury. At baseline this will be related to in hospital falls and for the six months prior to hospital admission 10. Use of walking aid 11. Mechanisms of change questionnaire, which asks questions about influences on the intervention target behaviour 12. Stroke Impact Scale v0.3 13. Caregiver Burden Scale (measured for carer)

Countries

England, Scotland, United Kingdom

Contacts

Public ContactAnne Forster
a.forster@leeds.ac.uk01274 393406

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026